Australian biopharmaceutical company Inccannex Healthcare develops therapeutic cannabinoid products and hallucinogens IXHL .
The study, co-led by the Director of the Clinical Psychedelics Laboratory at Monash University and Dr. Paul Ricknitsky, a member of the Incanex Scientific Advisory Board, is not only about safety and efficacy, but also about mental and physical health. It is set up to evaluate additional aspects of the company’s psilocybin program.
The 10-week treatment program included two dosing sessions with either psilocybin or active placebo. To date, 45 participants have been enrolled in the trial, 29 participants have currently completed the treatment protocol and post-treatment primary outcome assessments, and no safety issues have been observed.
Evaluation of this interim data is performed by an independent Data Security Monitoring Board (DSMB). Incanex will use the resulting recommendations to determine regulatory strategy and plan pivotal studies while continuing to collect data from this Phase 2 trial (recruitment will target 72 is in progress to complete a patient cohort of 10,000).
Incanex continues to benefit from the academic rigor that Monash University and Dr. Ricknitsky have brought to the development of this therapy. This should support our ambition to be the first company in the world to offer unique psychedelic remedies to the public. We look forward to providing further updates to our stakeholders following recommendations from the DSMB,” said Dr. Mark Bleackley, his CSO at the company.
Photo: Benzinga edited with photos by YAKOBCHUK VIACHESLAV and Alexander_Volkov for Shutterstock.
